Details for New Drug Application (NDA): 017808
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NDA 017808 describes MIACALCIN, which is a drug marketed by Mylan Ireland Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the MIACALCIN profile page.
The generic ingredient in MIACALCIN is calcitonin salmon. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.
The generic ingredient in MIACALCIN is calcitonin salmon. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.
Summary for 017808
| Tradename: | MIACALCIN |
| Applicant: | Mylan Ireland Ltd |
| Ingredient: | calcitonin salmon |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 017808
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIACALCIN | calcitonin salmon | INJECTABLE;INJECTION | 017808 | NDA | Mylan Institutional LLC | 67457-675 | 67457-675-02 | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) / 2 mL in 1 VIAL, MULTI-DOSE |
| MIACALCIN | calcitonin salmon | INJECTABLE;INJECTION | 017808 | NDA | Mylan Institutional LLC | 72078-038 | 72078-038-02 | 1 VIAL, MULTI-DOSE in 1 CARTON (72078-038-02) / 2 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 100 IU/ML | ||||
| Approval Date: | Jul 3, 1986 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200 IU/ML | ||||
| Approval Date: | Mar 29, 1991 | TE: | AP | RLD: | Yes | ||||
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